Suprachoroidal Triamcinolone in Macular Edema for Patients With Non-Infectious Uveitis Resistant to Subtenon Triamcinolon

NCT07145008 | Recruiting Early Phase 1

• 1 other identifier: 2024-234
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if a suprachoroidal triamcinolone injection can treat vision-threatening swelling in the center of the retina (macular edema) caused by non-infectious uveitis, especially in people who did not improve after a standard steroid injection around the eye (sub-Tenon injection). The main questions it aims to answer are: Does vision improve on the eye chart after the injection? Does the injection lower retinal swelling (reduction in thickness) within 3 months? Participants will: Have a pre-treatment check (vision test, slit-lamp exam, and a retinal scan called OCT). Receive one suprachoroidal triamcinolone injection under anesthetics drops in a sterile setting (operating room) with standard monitoring. Return for visits about 1 month and 3 months after treatment for repeat vision tests, and OCT scans. Contact the clinic if they notice pain, redness, new floaters, or worsening vision.

Conditions

Macular Edema (ME); Non Infectious Uveitis

Keywords

Suprachoroidal Triamcinolone; Macular Edema; Non infectious uveitis; Subtenon resistant

Outcome Measures

Primary Outcomes (1)

• Visual acuity improvement

  visual acuity improvement was defined as a gain of two or more lines in visual acuity or a reduction in logMAR values

  3 months

Secondary Outcomes (1)

• Central Macular Thickness

  3 Months

Study Arms (1)

Suprachoroidal Triamcinolone treatment arm

EXPERIMENTAL

Drug: Suprachoroidal triamcinolone acetonide injection

Interventions

Suprachoroidal triamcinolone acetonide injection DRUG

For suprachoroidal injection, we developed a custom-made delivery system to access the potential suprachoroidal space. A 1 mL tuberculin syringe fitted with a 27-gauge needle was prepared, and a plastic sleeve from a 24-26 G IV cannula was placed over the needle as a spacer to control penetration depth.

Suprachoroidal Triamcinolone treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-infectious uveitis complicated with macular edema
• Uveitic macular edema of less than four months' duration
• Macular edema persisted despite lack of intra-ocular inflammation
• No response to posterior sub-Tenon triamcinolone acetonide injections

You may not qualify if:

• Those with epiretinal membrane-associated macular edema
• Below 18 years

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Ibn Al-Haitham Eye Teaching Hospital

Baghdad, 10064, Iraq

RECRUITING

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Mohammed Suhail Al-Salam

CONTACT

+964 790 183 6367; mohammedsuhail@uomustansiriyah.edu.iq

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

IR (1)